Anlotinib Plus Penpulimab (AK105) for Chemo-refractory Metastatic Colorectal Cancer:ALTER-C003 (ALTER-C003)
2022年3月6日 更新者：YueJuan Cheng、Peking Union Medical College Hospital
Anlotinib Hydrochloride In Combination With Penpulimab (AK105) in Patients With Chemo-refractory Metastatic Colorectal Cancer, Open, Single Arm,Exploratory Clinical Trial(ALTER-C003)
A single-arm, open-label clinical trial, focus on the safety and efficacy of anlotinib hydrochloride in combination with Penpulimab (AK105) in patients with Chemo-refractory Metastatic Colorectal Cancer (mCRC)
調査の概要
研究の種類
介入
入学 (予想される)
32
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jianfeng Zhou
- 電話番号：011-86-10-69156114
- メール：ZhouJF@pumch.cn
研究場所
-
-
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Beijing、中国
- 募集
- Peking Union Medical College Hospital
-
コンタクト：
- jianfeng Zhou
- メール：ZhouJF@pumch.cn
-
Shenyang、中国
- まだ募集していません
- The First Hospital of China Medical University
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コンタクト：
- Xiujuan Qu
-
Shenyang、中国
- まだ募集していません
- The People's Hospital of Liaoning Province
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コンタクト：
- Du Zhenguang
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Beijing
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Beijing、Beijing、中国
- 募集
- Beijing Tiantan Hospital, Capital Medical University
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コンタクト：
- Xiaoyuan Li
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主任研究者：
- Xiaoyuan Li
-
Beijing、Beijing、中国
- まだ募集していません
- China-Japan Friendship Hospital
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主任研究者：
- Yuan Li
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コンタクト：
- Yuan Li
-
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Hebei
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Langfang、Hebei、中国
- まだ募集していません
- Hebei Petro China Central Hospital
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コンタクト：
- Qian Guo
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主任研究者：
- Qian Guo
-
Shijiazhuang、Hebei、中国
- まだ募集していません
- The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital)
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主任研究者：
- Ruixing Zhang
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コンタクト：
- Ruixing Zhang
- 電話番号：0086-311-86095757
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Tianjin
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Tianjin、Tianjin、中国
- 募集
- General Hospital of Tianjin Medical University
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients participate in the study voluntarily and sign informed consent with good compliance.
- Be 18 years of age or older on day of signing informed consent.
- Histological or cytological confirmation of Metastatic Colorectal Cancer(T1-4N0-2M1).
- At least one measurable lesion, with diameter ≥ 10mm measured by spiral MRI/CT scan per RECIST1.1.
- Participants must have received and progressed through or become intolerant to fluoropyrimidine, irinotecan, oxaliplatin, Exceptions may apply.
- Eastern Cooperative Oncology Group Performance Status 0 or 1.
- Life expectancy of at least 3 months.
- Main organs function is normal. (normal main organs function as defined below: Hemoglobin (Hb) ≥ 90 g/L, Neutrophils (ANC) ≥ 1.5×109/L, leucocyte (WBC) ≥ 3.0×109/L,Platelet count (PLT) ≥ 75×109/L,Total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 ×ULN, If liver metastasis is present，ALT and AST<5ULN ；Serum creatinine (Cr) ≤ 1.5× ULN or Creatinine Clearance rate(CCr) ≥60ml/min，Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) > 50%)
- The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 3 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after it.
Exclusion Criteria:
- Histological or cytological confirmation of mucinous adenocarcinoma or ovarian transcoelomic metastasis
- Patients who had previously received treatment with Anlotinib or anti-programmed cell death protein 1 (PD-1), programmed cell death protein 1 ligand 1 (PD-L1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors other immunotherapy against .
- Patients who had previously received treatment within 2 weeks or Participated in other anti-tumor clinical trials within 4 weeks.
- Patients with a large amount of pleural effusion or ascites requiring drainage.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- Patients who underwent major surgery within 4 weeks.
- Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers.
- Patients with a risk of gastrointestinal bleeding may not be enrolled.
- Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism.
- Patients with any severe and/or unable to control diseases，including： Patients with unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100) mmHg); Patients with Grade 2 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including male QTc≥450ms; female QTc≥470ms) and patients with Grade 2 or higher congestive heart failure (NYHA Classification); Patients with active or unable to control serious infections, which is over level 2 in CTC AE (4.0); Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L); Patients with kidney failure who require hemodialysis or peritoneal dialysis; Patients with interstitial lung disease with symptoms or signs of activity；Patients with a history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation > 1.0 g; Patients with any of the following coagulation functions are abnormal, including: Prothrombin time (PT)>ULN+4s, Activated partial thromboplastin time (APTT) >1.5ULN s, international normalized ratio (INR)>1.5; Patients with a seizure disorder who require pharmacotherapy.
- Patients who have got non remissive toxic reactions derived from any treatment, which is over level 1 in CTC AE (4.0).
- Has a diagnosis of immunodeficiency or is receiving chronic steroid therapy of prednisone ≥ 10 mg daily or any equivalent dose of corticosteroids.
- Has received a live vaccine or attenuated vaccine within 30 days prior to trial registration.
- Symptoms that affect oral medication and cannot be controlled through proper treatment (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.).
- Female patients who are pregnant or breastfeeding.
- Patients with drug abuse history and unable to get rid of or patients with mental disorders.
- Patients who had serious adverse effect to Anlotinib or Penpulimab or any of its excipients
- Known hypersensitivity to other Monoclonal Antibody or any of its excipients.
- Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Anlotinib+Penpulimab
|
ペンプリマブ 200 mg を 3 週間ごとに静脈内投与。
他の名前：
12mg、連続経口 2 週間停止 1 週間、21 日間の治療サイクル。
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-free survival (PFS)
時間枠：up to 24 months
|
Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
|
up to 24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
疾病制御率 (DCR)
時間枠：24ヶ月まで
|
疾患制御率は、RECIST v1.1 に従って、最良の反応が CR、PR、または安定疾患 (SD) であった被験者の割合として定義されます。
|
24ヶ月まで
|
|
Objective Response Rate (ORR)
時間枠：up to 24 months
|
Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the RECIST v1.1
|
up to 24 months
|
|
Duration of Response (DOR)
時間枠：up to 24 months
|
Duration of Response is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1 or death due to any cause, whichever occurs first.
|
up to 24 months
|
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Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
時間枠：Until 30 day safety follow-up visit
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Adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
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Until 30 day safety follow-up visit
|
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Overall Survival (OS)
時間枠：Up to 24 months
|
Overall Survival (OS) (median) is determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.
|
Up to 24 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of TB cells count and interleukin-6/8/10
時間枠：through study completion, an average of 2 year
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Objectives to analyse the subsets of TB cells and interleukin-6/8/10 associated treatment.
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through study completion, an average of 2 year
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Jianfeng Zhou、Peking Union Medical College Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年11月5日
一次修了 (予想される)
2022年8月23日
研究の完了 (予想される)
2023年8月23日
試験登録日
最初に提出
2021年7月5日
QC基準を満たした最初の提出物
2021年7月13日
最初の投稿 (実際)
2021年7月21日
学習記録の更新
投稿された最後の更新 (実際)
2022年3月8日
QC基準を満たした最後の更新が送信されました
2022年3月6日
最終確認日
2022年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。